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U.S. Department of Health and Human Services

Class 2 Device Recall Zoll MultiFunction Electrode

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  Class 2 Device Recall Zoll MultiFunction Electrode see related information
Date Initiated by Firm June 16, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on May 10, 2016
Recall Number Z-2334-2008
Recall Event ID 48753
510(K)Number K051076  
Product Classification Electrode, electrodcardiograph, multi-function - Product Code MLN
Product ZOLL OneStep Multi-Function Electrode; Adult Complete
Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring.
Code Information Lot #'s : 2108 & 2208
Recalling Firm/
Manufacturer		 Bio-Detek, Inc.
525 Narragansett Park Dr
Pawtucket RI 02861-4323
For Additional Information Contact SAME
401-729-1400
Manufacturer Reason
for Recall		 Multi-function electrode programmed as a Pediatric instead of Adult
FDA Determined
Cause 2		 Process control
Action Bio-Deteck notified the own label distributor and in cooperation the firm notified their customers by letter dated 6/16/08. Users are requested to return the lots and replacement product will be provided. Zoll issued and Urgent Device Correction letter on June 16, 2008 with instructions to follow if the device is used with the defective electrodes. If you have questions, contact ZOLL Medical Technical Service at 1-800-348-9011.
Quantity in Commerce 25 cases of 8/cs for each lot # ; Total of 400 units
Distribution MA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MLN and Original Applicant = ZOLL MEDICAL CORPORATION
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